论文部分内容阅读
目的帮助国内输液泵产品生产企业提高风险管理水平。方法阐述美国FDA对输液泵产品风险管理中的危害分析,对操作危害、环境危害、电气危害、硬件危害、软件危害、机械危害、生物学和化学危害、使用危害8大危害因素进行了示例说明。结果与结论学习美国FDA对输液泵的风险分析要求,可了解美国输液泵上市前对产品风险的识别要求,帮助国内企业在产品设计阶段考虑降低危害发生的风险,具有指导意义。
Objective To help domestic infusion pump manufacturers improve risk management. Methods The United States FDA on the risk analysis of infusion pump product risk management, the operational hazards, environmental hazards, electrical hazards, hardware hazards, software hazards, mechanical hazards, biological and chemical hazards, the use of hazards of eight major hazards were illustrated . RESULTS AND CONCLUSIONS It is instructive to learn the requirements of the FDA for the risk analysis of infusion pumps to understand the identification requirements of product infusion pumps prior to the listing of infusion pumps in the United States and to help domestic enterprises consider reducing the risk of occurrence of hazards during the product design stage.